All subjects are to complete a 4 week titration period at which time subjects will be titrated up to a maintenance level of study drug. Subjects will then take the maintenance dose of study drug for an additional 20 weeks.

During the study, subjects will receive ancillary therapy including advice on diet and exercise

Eligibility

Ages Eligible for Study:

18 Years to 65 Years

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Female and male subjects must be 18 to 65 years of age;

Have body mass index (BMI) greater or equal to 27 and less than or to equal 43kg/m2;

Meet criteria for major depression

Women of child-bearing potential, must be non-lactating and agree to use effective contraception throughout the study period and 30 days after discontinuation of study drug;

Able to comply with all required study procedures and schedule;

Able to speak and read English;

Willing and able to give written informed consent

Exclusion Criteria:

Obesity of known endocrine origin

Serious medical condition

History of drug or alcohol abuse or dependence

Use of excluded concomitant medications

History of surgical or device (e.g. gastric banding) intervention for obesity;

History or predisposition to seizures

Pregnant or breast-feeding women or planning to become pregnant during the study period or within 30 days of discontinuing study drug;

Planned surgical procedure that can impact the conduct of the study;

Use of investigational drug, device or procedure within 30 days prior to Screening;

Participation in any previous clinical trial conducted by Orexigen Therapeutics;

Any condition which in the opinion of the investigator makes the subject unsuitable for inclusion in the study.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00624858